Services

Product Characterisation

Inhalation product testing and characterisation to customer requirements and high level of quality.

Inhalation Product testing and characterisation

Inhalation product testing and characterisation requires product understanding as well as capabilities for performing the tests. MVIC has the experience to do the right tests with procedures that are standardised or matched to customer requirements with high level of quality. MVIC are proud to provide individualized aerosol characterisation according to our clients’ precise needs and specifications.

MVIC characterization technologies to ensure a seamless development of inhalation products

Aerodynamic particle size distribution (APSD) is along with delivered dose crucial to fully understand the impact of a candidate aerosol. MVIC is a full-service partner with a unique ability to assist in product characterisation of inhaled pharmaceuticals. We are utilizing a silico modelling of lung deposition and determine PK outcomes based on in vitro data. Our aerosol characterisation methods include:

Impactor Based Tests and lung deposition prediction

Particle size determines where in the airways a certain drug will be deposited following an inhalation. In standard USP throat or anatomically realistic mouth throat models and lung simulators MVIC is utilizing different instruments in impactor testing. Methods include Next Generation Impactor (NGI), Andersen Cascade Impactor (ACI) and Multi-stage Liquid Impinger (MLI). MVIC use throat models and realistic inhalation flow profiles as in vitro methods to predict in vivo outcome.

Spray Pattern (SP)/Plume Geometry (PG)

We are utilizing a measurement system (Envision system from Oxford Lasers) to characterise spray pattern and plume geometry. It is an open system with a sampling rate up to 500 Hz, that can be used at variable distances. SP and PG can be used with inhaler specific housing for “push through” air flow triggering.

Delivered Dose (DD)

A critical attribute for inhaled drugs is that the same dose is given at each inhalation. MVIC has methods for determining the quality, efficacy and safety of inhaled drugs. We are using both standard Dosage Unit Sampling Apparatus (DUSA) as specified in Pharmacopeia, but also faster and less laborious methods. Together with our clients we adapt bespoke dose collection systems and design automation systems (semi- and full automation).

Droplet and Particle Size Distribution (PSD)

Among others MVIC can offer:

  • Laser diffraction
  • Aerodynamic Particle Sizer combined with Impactor inlet for screening tests
  • Open and closed Inhalation cells
  • PSD of liquid and powder products